VBIO 8-K
Valion Bio, Inc. (VBIO)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 7.01 Regulation FD Disclosure.
On June 25, 2025, Tivic Health Systems, Inc. (the “Company”) issued a press release announcing completion of the Optimization Study for its non-invasive vagus nerve stimulation device. A copy of this press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K (this “Current Report”) and is incorporated by reference herein.
The information set forth under Item 7.01 of this Current Report, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of such section. The information in Item 7.01 of this Current Report, including Exhibit 99.1, shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any incorporation by reference language in any such filing, except as expressly set forth by specific reference in such a filing. This Current Report will not be deemed an admission as to the materiality of any information in this Current Report that is required to be disclosed solely by Regulation FD.
Forward-Looking Statements
This Current Report, including Exhibit 99.1 attached hereto, contains certain forward-looking statements that involve substantial risks and uncertainties. When used herein, the terms “anticipates,” “expects,” “estimates,” “believes,” “will” and similar expressions, as they relate to us or our management, are intended to identify such forward-looking statements.
Forward-looking statements in this Current Report, including Exhibit 99.1 attached hereto, or hereafter, including in other publicly available documents filed with the Securities and Exchange Commission (the “Commission”), reports to the stockholders of the Company and other publicly available statements issued or released by us involve known and unknown risks, uncertainties and other factors which could cause our actual results, performance (financial or operating) or achievements to differ from the future results, performance (financial or operating) or achievements expressed or implied by such forward-looking statements. Such future results are based upon management’s best estimates based upon current conditions and the most recent results of operations. These risks include, but are not limited to, the risks set forth herein and in such other documents filed with the Commission, each of which could adversely affect our business and the accuracy of the forward-looking statements contained herein. Our actual results, performance or achievements may differ materially from those expressed or implied by such forward-looking statements.
Item 9.01 Financial Statements and Exhibits.
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Exhibits. |
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Description |
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99.1 |
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Press Release of Tivic Health Systems, Inc., dated June 25, 2025. |
104 |
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Cover Page Interactive Data File (formatted in Inline XBRL and contained in Exhibit 101). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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TIVIC HEALTH SYSTEMS, INC. |
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June 25, 2025 |
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/s/ Lisa Wolf |
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Name: Lisa Wolf |
Exhibit 99.1
Tivic Health Completes Optimization Study for its Non-Invasive Vagus Nerve Stimulation Device
Breakthrough Findings to be Reported Later this Year and Applied to Upcoming Phase I Clinical Trial
FREMONT, Calif. – June 25, 2025 – Tivic Health® Systems, Inc. (Nasdaq: TIVC), a diversified immunotherapeutics company developing treatments that stimulate immune pathways to treat disease, today announced it has completed all study visits in the Optimization Study for its patent pending, non-invasive cervical vagus nerve stimulation (ncVNS) device. Initial findings reinforce the importance of personalization for therapeutic efficacy. Tivic expects to release the study results later this year.
The study was conducted by The Feinstein Institute of Bioelectronic Medicine with the objective of identifying device parameters that optimally influence autonomic nervous system function. These comprised frequency, amplitude, electrode positioning and personalization, all key parameters previously under-researched, especially for non-invasive VNS treatments. Key findings from the first stages of this study were previously presented in a poster titled, “Autonomic, Cardiac, and Neural Effects from Non-Invasive Cervical Vagus Nerve Stimulation,” at the Sixth Bioelectronic Medicine Summit: Neurotechnologies for Communities & Individuals, on March 4, 2025.
“This study has provided Tivic with key breakthroughs in the scientific understanding of how to most effectively deliver stimulation to the vagus nerve and thereby the modulation of the pathways implicated in many prevalent and debilitating diseases,” stated Tivic Health’s Chief Executive Officer, Jennifer Ernst. “As we prepare to report these new findings, we are more confident than ever that our novel bioelectronic approach to VNS has the potential to form the basis of future compelling and highly differentiated treatments for large patient populations with unmet clinical needs,” added Ernst.
Market Opportunity
Polaris Market Research estimates the global VNS market will grow from $8.59 billion in 2021 to $21.3 billion in 2030, a 10.6% CAGR over the forecast period. Additionally, IDTechEx has forecast peripheral nerve stimulation, the segment targeted by Tivic Health, will grow at 35% CAGR, one of the fastest growth segments in bioelectronic medicine.
About the Vagus Nerve
The vagus nerve is the longest autonomic nerve in the body and regulates many organ systems associated with chronic disease. VNS is approved by the US Food & Drug Administration for treatment-resistant epilepsy and depression, cluster and migraine headaches, and stroke rehabilitation. It is being studied for other neurological, cardiac, and immune conditions. However, many of the applications of VNS rely on surgical implants, which are not suitable for many patients.
About Tivic Health Systems, Inc.
Tivic Health seeks to treat underserved medical conditions through biochemical and bioelectric therapies that modulate patients’ immune system. The company's lead biopharma product candidate, the TLR5 agonist Entolimod™ to treat ARS, has been granted Fast Track and Orphan Drug designation by the FDA. Tivic Health's bioelectronic program is developing non-invasive medical devices that personalize key stimulation to modulate the pathways implicated in many prevalent and debilitating diseases.
Tivic Health's first FDA approved product ClearUP™ is proven to treat sinus pain and pressure, and is available through online retailers and commercial distributors. For more information about Tivic Health, visit: https://ir.tivichealth.com.
Forward-Looking Statements
This press release may contain “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Tivic Health Systems Inc.’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate, including as a result of the company’s interactions with and guidance from the FDA and other regulatory authorities; changes to the company’s relationship with its partners; failure to obtain FDA or similar clearances or approvals and noncompliance with FDA or similar regulations; the company’s future development of its ncVNS treatment, Entolimod and Entolasta; changes to the company’s business strategy; timing and success of clinical trials and study results, including the ncVNS optimization study with The Feinstein Institute of Bioelectronic Medicine; regulatory requirements and pathways for approval; changes in the markets and industries in which the company does business; consummation of any strategic transactions; the company’s need for, and ability to secure when needed, additional working capital; the company’s ability to maintain its Nasdaq listing; and changes in tariffs, inflation, legal, regulatory, political and economic risks. Accordingly, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of risks and uncertainties relevant to the company, and other important factors, see Tivic Health’s filings with the SEC, including, its Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 21, 2025, under the heading “Risk Factors”, as well as the company’s subsequent filings with the SEC. Forward-looking statements contained in this press release are made as of this date, and the company undertakes no duty to update such information except as required by applicable law.
Media Contact:
Deanne Eagle or Laura Min Jackson
Investor Contact:
Hanover International, Inc.